Needle sticks are the most frequent and most distressing medical procedure children experience. Resultant needle phobia decreases parents'compliance with immunizations and affects patients'subsequent interactions with health care systems, resulting in delayed diagnoses, refusal to donate blood, and even death. Current products rely on health care professionals to voluntarily use messy, ineffective, and time-consuming interventions for a pain many consider insignificant. An immediately effective reusable pain relief device available directly to consumers could reduce morbidity and suffering worldwide. The market for rapid venipuncture pain relief is large;the market for immediate immunization relief is larger and untapped. A small non-invasive device placed centimeters proximal to the needle site significantly reduced venipuncture pain in adults without impacting IV start success. Phase I of this project evaluates pain and anxiety relief, ease of use, and product acceptance using the device versus standard care in 60 children ages 4 - 6 receiving school-entry immunizations. Concurrently, the prototype will be enhanced to promote pediatric pain relief with distracting cute designs. Phase II of the project is a three arm, placebo-controlled trial to demonstrate pain reduction in four age groups receiving scheduled vaccinations: 4-6 months (n=120), 12-15 months (n=60), 4-6 years (n=60), and 11-12 years (n=75). Using a variety of age-appropriate measures, pain relief will be assessed by videotape coding by blinded researchers, and by parent, nurse, and child self-report when appropriate. Patients will be randomized to one of three groups: placebo, standard care, and using the device. Further professional design will incorporate microelectronic enhancement, internal cooling components, the option to grab and bunch skin for self-injection, durability testing, and power efficiency improvement. Copious literature alludes to the impact of pediatric needle pain and the lack of a good solution. The proposed device overcomes failings in existing products and is easy for consumers to bring to the doctor and apply themselves. These projects will improve and demonstrate the efficacy of a much-needed intervention for pain inflicted on every child. PUBLIC HEALTH RELEVANCE: This project seeks to optimize and test in children a novel inexpensive reusable device to reduce or eliminate immunization pain. Pediatric needle pain leads to reluctance to access health care, delayed diagnoses, noncompliance with vaccines and treatment, and refusal to donate blood. Reducing needle pain is an overlooked opportunity to reduce suffering worldwide.